Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily

NCT03067415 | Unknown Phase 2

• 1 other identifier: 171GLC16020
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Exploratory trial to evaluate the efficacy and safety of D565H twice daily versus D565 once daily.

Conditions

Glaucoma, Primary Open Angle; Ocular Hypertension

Keywords

Glaucoma, Primary Open Angle; Ocular hypertension; CKD-351

Outcome Measures

Primary Outcomes (1)

• Change in mean intraocular pressure at 4 weeks compared to baseline

  Mean baseline intraocular pressure change Mean intraocular pressure change after 4 weeks

  Baseline, 4 weeks

Secondary Outcomes (2)

• Change in mean intraocular pressure at 2 weeks compared to baseline

  Baseline, 2 weeks

• Changes in intraocular pressure by measurement time

  2 weeks, 4 weeks

Other Outcomes (1)

• Safety assessed by the incidence of adverse event, History, Medication

  up to 4 weeks

Study Arms (2)

D565H(Latanoprost 25㎍/㎖)

EXPERIMENTAL

D565H(Latanoprost 25㎍/㎖)

Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖)

D565(Latanoprost 50㎍/㎖)

ACTIVE COMPARATOR

D565(Latanoprost 50㎍/㎖)

Drug: D565H(Latanoprost 25㎍/㎖); Drug: D565(Latanoprost 50㎍/㎖)

Interventions

D565H(Latanoprost 25㎍/㎖) DRUG

D565H twice daily

Also known as: Arm A

D565(Latanoprost 50㎍/㎖); D565H(Latanoprost 25㎍/㎖)

D565(Latanoprost 50㎍/㎖) DRUG

D565 once daily

Also known as: Arm B

D565(Latanoprost 50㎍/㎖); D565H(Latanoprost 25㎍/㎖)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than the age of 19 years old
• Subjects who has primary Open-Angle Glaucoma or Ocular Hypertension
• Subjects who sign on an informed consent form willingly

You may not qualify if:

• Subjects with IOP(Intraocular Pressure) measured at Visit 1 and Visit 2(AM 09:00) above 35 mmHg at more than one eye
• Subjects with a maximum corrected visual acuity of less or than 0.3 in the selected evaluation eye at visit 2
• Subjects who were diagnosed as below with monocular or both eye
• Acute or Chronic Closed-Angle Glaucoma
• Secondary Glaucoma
• Pseudoexfoliation Glaucoma
• Neovascular Glaucoma
• aphakia
• phacocyst capsular torn intraocular lens
• Subjects with significant eye symptoms/signs(Abscesses, diplopia) or severe visual field impairment(Mean Deviation -25dB or more)
• Subjects with severe dry eye syndrome or progressive retinal disease(Retinal degeneration, Diabetic retinopathy, Retinal detachment, Macular edema)
• Subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months
• Subjects who have medical history following
• Glaucoma surgery
• Subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hosipital

Seoul, Jongno, South Korea

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• KiHo Park

  Seoul National University Hosipital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KiHo Park

CONTACT

82-10-3458-3172; kihopark@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assignment

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: March 30, 2017
• Primary Completion: September 10, 2017
• Study Completion: September 30, 2017
• Last Updated: July 21, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)